It was reported a patient began to experience limited range of motion, difficulty ambulating, pain, swelling, and stiffness about one month post implantation, underwent a manipulation under anesthesia.The scar tissue was easily released and the procedure was completed without complications.All implants remain in place.
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted. additional associated products: (b)(6) persona femur trabecular metal (cr) narrow porous lot# 64278729.(b)(6) persona articular surface medial congruent (mc) right 10 mm lot# 64375813.(b)(6) nexgen complete knee solution, trabecular metal std pri patella lot# 64227939.
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